Systematic review: hepatosplenic T‐cell lymphoma on biologic therapy for inflammatory bowel disease, including data from the Food and Drug Administration Adverse Event Reporting System. Issue 5 (28th January 2020)

• Record Type: Journal Article
• Authors: Shah, Eric D.; Coburn, Elliot S.; Nayyar, Anil; Lee, Kerry Jo; Koliani‐Pace, Jenna L.; Siegel, Corey A.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 51:Issue 5(2020)
• Page Start: 527
• Page End: 533
• Publication Date: 2020-01-28
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.15637
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Hepatosplenic T‐cell lymphoma (HSTCL) is a rare, poorly treatable malignancy associated with therapy for IBD. Current knowledge of HSTCL risk in IBD comes from an era of step‐up therapy, before earlier use of biologics or combination therapy was advocated to achieve deep mucosal healing. HSTCL risk among newer biologic classes has also not been evaluated. Aims: To systematically characterise the association of HSTCL with biologic therapy for IBD. Methods: We conducted a literature search and query of the Food and Drug Administration Adverse Event Reporting System to summarise HSTCL cases among IBD patients with prior biologic exposure. Demographics and immunosuppression exposure were extracted. Patients were stratified by current regimen (combination therapy, biologic monotherapy or no biologic), and biologic class (anti‐TNF, anti‐integrin, anti‐interleukin 12/23). Results: Sixty‐two cases of HSTCL were identified from 2486 abstracts and 181 FDA Adverse Events Reporting System reports. The median age of affected patients was 28 years (range 12‐81), and 83.6% were male, 84.7% had Crohn's disease. Five of 62 patients had no reported azathioprine/mercaptopurine exposure. Three patients within the cohort developed HSTCL after exposure to natalizumab, vedolizumab or ustekinumab; all three also had anti‐TNF and azathioprine/mercaptopurine exposure. Forty‐three of 49 (87.8%) patients with known outcomes died with a median survival of 5 months. Conclusions: Consistent with existing data, almost all identified HSTCL cases among IBD patients on biologic therapy had azathioprine/mercaptopurine exposure, and all cases on patients exposed to biologics had anti‐TNF exposure. These data suggest initiating a patient‐centred discussion before starting anti‐TNF therapy or other biologics.